Warfarin Sodium

Basic Information

Product Name

Warfarin Sodium

FDA Product Code

55154-4696

Regulatory Information

NDC Product Code

55154-4696

Application Number

ANDA040301

Marketing Category

C73584

Effective Date

June 29, 2019

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

WARFARIN SODIUM

Quantity: 2.5 mg in 1 1

Code: 6153CWM0CL

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

Active Moieties

WARFARIN

Code: 5Q7ZVV76EI

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS LACTOSE

STARCH, CORN

D&C YELLOW NO. 10

MAGNESIUM STEARATE

FD&C BLUE NO. 2

Active Moieties

WARFARIN